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Programalith #'s 221, 222, 221A & 222A

by Pacesetter Systems 510(k)

Active United States

510(k) K801978

Overview

The Programalith #'s 221, 222, 221A & 222A is an implantable pacemaker pulse-generator device designed to regulate heart rhythm through electrical stimulation. This device is classified under the cardiovascular medical specialty and is intended for patients requiring cardiac pacing support.

The device is supplied as a single-use implantable device and requires specific storage conditions as per manufacturer guidelines. It received FDA 510(k) clearance with K-number K801978 on September 26, 1980, and is regulated under product code DXY with device class 3.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801978 Date26 Sep 1980ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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